| CTRI Number |
CTRI/2025/07/091562 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing the effectiveness of Buzzy device and the usual method in reducing pain and stress during dental injections in children |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of Buzzy and conventional technique in reducing pain and anxiety during Inferior Alveolar Nerve Block in children: A Split-Mouth Randomised Crossover Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nabiha Mahmoud |
| Designation |
PG student |
| Affiliation |
Government Dental College and Research Institute, Bangalore |
| Address |
Room no. 5, Department of Pediatric and Preventive dentistry, Government Dental College and Research Institute, Victoria hospital Campus, Fort, Bangalore-560002
Bangalore
KARNATAKA
560002
India |
| Phone |
8279341862 |
| Fax |
|
| Email |
nabihamhmd08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Srinath |
| Designation |
Head of Department |
| Affiliation |
Government Dental College and Research Institute, Bangalore |
| Address |
Room no. 5, Department of Pediatric and Preventive dentistry, Government Dental College and Research Institute, Victoria hospital Campus, Fort, Bangalore-560002
Bangalore
KARNATAKA
560002
India |
| Phone |
|
| Fax |
|
| Email |
srinath.krishnappa@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nabiha Mahmoud |
| Designation |
PG student |
| Affiliation |
Government Dental College and Research Institute, Bangalore |
| Address |
Room no. 5, Department of Pediatric and Preventive dentistry, Government Dental College and Research Institute, Victoria hospital Campus, Fort, Bangalore-560002
Bangalore
KARNATAKA
560002
India |
| Phone |
8279341862 |
| Fax |
|
| Email |
nabihamhmd08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Research Institute, Victoria hospital Campus, Fort, Bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
Nabiha Mahmoud |
| Address |
Room no. 5, Department of Pediatric and Preventive dentistry, Government Dental College and Research Institute, Victoria hospital Campus, Fort, Bangalore-560002 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nabiha Mahmoud |
Government Dental College and Research Institute |
Room no 5, Department of Pediatric and Preventive Dentistry, Government Dental College and Research Institute, Bangalore - 560002
Bangalore
KARNATAKA |
8279341862
nabihamhmd08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee and Review Board, GDCRI, Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
requiring extraction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buzzy device(Pain Care Labs,
Atlanta, GA, USA) 1 minute before and during standard inferior alveolar nerve block |
A vibrotactile, cold device placed on the angle of the mandible extraorally for 1 minute before nerve block followed by the inferior alveolar nerve block performed using a 27-gauge needle with 2% lidocaine + 1:80,000 epinephrine, injected at a slow rate of 1 mL/min |
| Comparator Agent |
Standard inferior alveolar nerve block technique |
The inferior alveolar nerve block will be performed using a 27-gauge needle with 2% lidocaine + 1:80,000 epinephrine, injected at a slow rate of 1 mL/min |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy, co-operative children aged 8-10 years with no prior experience of an intraoral local anesthetic injection
2. Mandibular teeth indicated for extraction that warrants the use of bilateral Inferior Alveolar Nerve Block (IANB)
3. Children with Frankl behavior rating in category 3 and 4
|
|
| ExclusionCriteria |
| Details |
1. Children with known allergy to local anesthesia or its components
2. Children on long term systemic medications
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage success of adequate anesthesia |
10 minutes after inferior alveolar nerve block administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain Perception |
Before and immediately after inferior alveolar nerve block administration |
| Behavioral Response to Pain |
During inferior alveolar nerve block administration |
| Physiological response to anxiety |
Before, during and after inferior alveolar nerve block |
| Parental and child acceptance of Buzzy device |
After inferior alveolar nerve block administration |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single-blinded, randomised, split-mouth, crossover clinical trial comparing the efficacy of the BUZZY device and the conventional technique in reducing pain and anxiety during inferior alveolar nerve block (IANB) in children aged 8–10 years. A total of 44 healthy and cooperative children(88 sites) who require bilateral IANB for mandibular teeth extraction will be selected based on specific inclusion and exclusion criteria.
Participants will be randomly allocated to receive IANB with the BUZZY device in one visit and conventional IANB without the device in a crossover manner during the second visit after a two-week washout period. The primary outcome measures will include the percentage success of adequate anesthesia evaluated through subjective and objective signs 10 minutes after the injection, pain perception using the Wong-Baker Facial Rating Scale before and after the injection, behavioral response using the FLACC scale during the injection, physiological indicators of anxiety such as pulse rate measured preoperatively, intraoperatively, and postoperatively using a fingertip pulse oximeter. The secondary outcome includes the parental and child acceptance of the BUZZY device as a counterstimulation aid during local anesthesia. |